Diabetes mellitus, or diabetes, is a disease characterized by elevated levels of plasma glucose. Uncontrolled hyperglycemia is associated with increased risk of vascular disease including, nephropathy, neuropathy, retinopathy, hypertension, and death. There are two major forms of diabetes: Type 1 diabetes (or insulin-dependent diabetes) and Type 2 diabetes (or non insulin-dependent diabetes). The American Diabetes Association has estimated that approximately 6% of the world population has diabetes.
The goal of diabetic therapy is to maintain a normal level of glucose in the blood. The American Diabetic Association has recommended that diabetics monitor their blood glucose level at least three times a day in order to adjust their insulin dosages and/or their eating habits and exercise regimen. However, glucose tests can only measure a point in time result and do not provide an overall assessment of glycemic control over a period of time. The measurement of glycated albumin has proven to be valuable measure of the effectiveness of glycemic control over the preceding 2-3 weeks. The basis for measuring glycated albumin depends on the nonenzymatic glycosylation of albumin and is directly proportional to the level of glucose in plasma over a period of time. The half-life of albumin in plasma is 2-3 weeks and as glycosylation occurs at a constant rate over time the level of glycated albumin provides a measure of the average blood glucose level over the preceding two to three weeks.
Frequent monitoring of the individual's glycated albumin would provide an accurate assessment of overall effectiveness of glycemic control in the individual.
Current methodology for performing tests for glycated albumin are complex to perform or require expensive instrumentation and are generally performed in laboratories. It would be advantageous to develop a simplified point-of-care assay that could be utilized in a doctor's office or by the patient and there is intensive research to develop such a test.
The present invention describes a simplified point-of-care assay that utilizes disposable test strips and a reusable measuring instrument.